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FDA 510(k)

Ahead 300

K-Number: K161068 · 2016-09-22

ApplicantBrainscope Company, Inc.
Decision Date2016-09-22
Product CodePIW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Ahead 300 is a medical device manufactured by Brainscope Company, Inc.. It received FDA 510(k) clearance on 2016-09-22 under approval number K161068. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ahead 300?

Ahead 300 is a medical device that received FDA 510(k) clearance on 2016-09-22. It is manufactured by Brainscope Company, Inc.. The 510(k) number is K161068.

When was Ahead 300 approved by the FDA?

Ahead 300 received FDA 510(k) clearance on 2016-09-22, under approval number K161068.

What company makes Ahead 300?

Ahead 300 is manufactured by Brainscope Company, Inc..

What is the FDA product code for Ahead 300?

The FDA product code for Ahead 300 is PIW.

Other Devices by Brainscope Company, Inc.

K181785Modified BrainScope One K181179BrainScope One K190815BrainScope TBI K183241BrainScope TBI (Model: Ahead 400)

Related Devices (Code: PIW)

K181785Modified BrainScope OneBrainscope Company, Inc. K181179BrainScope OneBrainscope Company, Inc. K190815BrainScope TBIBrainscope Company, Inc. K183241BrainScope TBI (Model: Ahead 400)Brainscope Company, Inc. K231914Nurochek-II SystemHeadsafe Mfg Pty, Ltd. K243426Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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